Catalog Number

001-756

Brand Name

ShaRing X-Series Sensor Kit Size 1 & 2

Version/Model Number

001-756

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EGZ

Product Code Name

Holder, Film, X-Ray

Public Device Record Key

c2fd1a33-c12b-4941-a2de-a0c99f1e9351

Public Version Date

January 08, 2021

Public Version Number

1

DI Record Publish Date

December 31, 2020

Package DI Number

10856200001753

Quantity per Package

12

Contains DI Package

00856200001756

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX